Effect of Chosen Treatment Methods in Patients With Cervical Spine Osteoarthritis

NCT03683602 | Completed

• 1 other identifier: NECK/2018
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

Brief Summary

Abstract Objective: To compare effect of PNF therapy with manual therapy on pain, associated symptoms, range of motion and functioning in patients with cervical spine osteoarthritis. Design: Parallel group, single-center, double-blinded randomized controlled trial. Setting: Outpatient clinic in hospital KCRiO. Subject: Eligible patients were female adults with chronic pain of cervical spine due to osteoarthritis of vertebral body and intervertebral disc confirmed by X-ray. Interventions: Group I (PNF group) was treated according to PNF concept, while Group II according to manual therapy (manual therapy group). Both groups received 10 days of treatment, 45 minutes each day. Main measures: Primary outcomes measures were Oswestry scale and range of motion (ROM). Secondary outcomes measures were subjective evaluation of cervical pain according to VAS scale and associated symptoms (headache, vertigo, ROM of shoulder joints, balance). For each scale results were measured at baseline, after two weeks of intervention and after a three-month follow-up period without therapy. Keywords: neck pain, PNF, manual therapy

Conditions

Cervical Spine Osteophyte

Keywords

PNF, manual therapy, neck pain

Outcome Measures

Primary Outcomes (1)

• Oswestry scale

  Oswestry Disability Index (ODI) can be used for evaluation both cervical and lumbar spine. It is the most common method used for disability evaluation of patients with neck pain. It consits of questiones which evaluate how the pain limits activities. There are 10 questiones concerning ADLs.

  Change from baseline Oswesstry scale at 2 weeks.

Secondary Outcomes (3)

• VAS scale

  baseline, two weeks, 3 months

• assessment of the occurrence of vertigo, balance problems,nausea,limited ROM in shoulder joints

  baseline, two weeks, 3 months

• ROM evaluation

  baseline, two weeks, 3 months

Study Arms (2)

PNF group

EXPERIMENTAL

PNF techniques, patterns, re-education of postural control, once a day 10 days,

Other: PNF group

Manual therapy group

ACTIVE COMPARATOR

traction, joints mobilization, pos-isometric relaxation, once a day 10 days

Other: manual therapy group

Interventions

PNF group OTHER

PNF is used in treatment of musculoskeletal pain of cervical and lumbar spine. Proprioceptive neuromuscular facilitation is a rehabilitation concept widely used by physiotherapists in many countries, in which stimulation of central nervous system is to achieve the highest possible functional level

PNF group

manual therapy group OTHER

Manual therapy is used for an assessment and treatment of joint and soft tissues. The basic therapeutic tool is mobilisation. In the study joint mobilisation according to Kaltenborn-Evjenth Manual Therapy was used. The joint were mobilised with low velocity passive movements in the whole or end range. Spinal manipulation wasn't used. Liter Exelby reports that manual therapy with joints mobilisation was quite effective in improvement of functional movements and decreasing of pain.

Manual therapy group

Eligibility Criteria

• Age: 45 Years - 65 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• age 45-65,
• female gender,
• cervical pain due to osteoarthritis of vertebral body and intervertebral disc confirmed by X-ray,
• chronic pain lasting more than 13 weeks, verbal contact,
• intact cognitive functions and voluntary consent for the study.

You may not qualify if:

• birth or aquired deficits,
• cervical spine injury,
• osteoporosis,
• cervical spine instability,
• myelopathy,
• signs of nerve root compression of C1-C8, such as paresis, muscle loss, hyporeflexia, use of analgesics,
• anti-inflammatory drugs or myorelaxants.

Sponsors & Collaborators

• Jagiellonian University: lead

Study Sites (1)

Krakowskie Centrum Rehabilitacji i Ortopedii

Krakow, Malopolska, 30-224, Poland

Location

Related Publications (10)

• Nazari G, Bobos P, Billis E, MacDermid JC. Cervical flexor muscle training reduces pain, anxiety, and depression levels in patients with chronic neck pain by a clinically important amount: A prospective cohort study. Physiother Res Int. 2018 Jul;23(3):e1712. doi: 10.1002/pri.1712. Epub 2018 Mar 14.

  PMID: 29536618 RESULT

• Malik AA, Robinson S, Khan WS, Dillon B, Lovell ME. Assessment of Range of Movement, Pain and Disability Following a Whiplash Injury. Open Orthop J. 2017 Jul 19;11:541-545. doi: 10.2174/1874325001711010541. eCollection 2017.

  PMID: 28839498 RESULT

• Vincent K, Maigne JY, Fischhoff C, Lanlo O, Dagenais S. Systematic review of manual therapies for nonspecific neck pain. Joint Bone Spine. 2013 Oct;80(5):508-15. doi: 10.1016/j.jbspin.2012.10.006. Epub 2012 Nov 16.

  PMID: 23165183 RESULT

• de Koning CH, van den Heuvel SP, Staal JB, Smits-Engelsman BC, Hendriks EJ. Clinimetric evaluation of active range of motion measures in patients with non-specific neck pain: a systematic review. Eur Spine J. 2008 Jul;17(7):905-21. doi: 10.1007/s00586-008-0656-3. Epub 2008 Apr 22.

  PMID: 18427843 RESULT

• Ylinen J, Kautiainen H, Wiren K, Hakkinen A. Stretching exercises vs manual therapy in treatment of chronic neck pain: a randomized, controlled cross-over trial. J Rehabil Med. 2007 Mar;39(2):126-32. doi: 10.2340/16501977-0015.

  PMID: 17351694 RESULT

• Cunha AC, Burke TN, Franca FJ, Marques AP. Effect of global posture reeducation and of static stretching on pain, range of motion, and quality of life in women with chronic neck pain: a randomized clinical trial. Clinics (Sao Paulo). 2008 Dec;63(6):763-70. doi: 10.1590/s1807-59322008000600010.

  PMID: 19060998 RESULT

• Lluch E, Arguisuelas MD, Coloma PS, Palma F, Rey A, Falla D. Effects of deep cervical flexor training on pressure pain thresholds over myofascial trigger points in patients with chronic neck pain. J Manipulative Physiol Ther. 2013 Nov-Dec;36(9):604-11. doi: 10.1016/j.jmpt.2013.08.004. Epub 2013 Oct 21.

  PMID: 24152997 RESULT

• Falla D, O'Leary S, Farina D, Jull G. Association between intensity of pain and impairment in onset and activation of the deep cervical flexors in patients with persistent neck pain. Clin J Pain. 2011 May;27(4):309-14. doi: 10.1097/AJP.0b013e31820212cf.

  PMID: 21178596 RESULT

• Cleland JA, Childs JD, Fritz JM, Whitman JM, Eberhart SL. Development of a clinical prediction rule for guiding treatment of a subgroup of patients with neck pain: use of thoracic spine manipulation, exercise, and patient education. Phys Ther. 2007 Jan;87(1):9-23. doi: 10.2522/ptj.20060155. Epub 2006 Dec 1.

  PMID: 17142640 RESULT

• Gallagher EJ, Liebman M, Bijur PE. Prospective validation of clinically important changes in pain severity measured on a visual analog scale. Ann Emerg Med. 2001 Dec;38(6):633-8. doi: 10.1067/mem.2001.118863.

  PMID: 11719741 RESULT

MeSH Terms

Conditions

Neck Pain

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Tomasz Maicki, PhD

  Jagiellonian University Colegium Medicum

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PhD

Study Record Dates

• First Submitted: September 19, 2018
• First Posted: September 25, 2018
• Study Start: January 1, 2011
• Primary Completion: April 1, 2013
• Study Completion: April 1, 2014
• Last Updated: September 25, 2018

Record last verified: 2018-09

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, ICF
• Time Frame: available
• Access Criteria: on email request: tomasz.maicki@uj.edu.pl

Locations

PL (1)